Job Summary
About the company
Our partner develops amazing quality management software for the whole enterprise. Our cloud-based platform, which includes modules for Document Management, Issue/CAPA, Training, Audits and Supplier Management, offers companies the opportunity to improve quality compliance and save money.
Their business is built on an established and well-respected client base, and growing rapidly. We’ve been able to cultivate an environment that is both collegial and entrepreneurial, but still retains a bit of early-stage fun. Our headquarters is located in Narberth, PA.
Our partner develops amazing quality management software for the whole enterprise purpose-built for Life Sciences companies. Our cloud-based platform offers companies the opportunity to improve quality compliance and save money. A sneak peek at the modules of our quality management system:
- DOCUMENTS MODULE: Manage the full document lifecycle with every version from draft to retirement.
- Utilize built-in Part 11/Annex 11 compliant electronic signatures
- Automate and enforce workflows that match your current processes
- Set access rights based on user roles/permissions
- Query data, even within documents, with the Keyword Search feature
- Collaborative editing with Microsoft Office for the web
- TRAINING MODULE: Easily create, track, and complete training from SOP review to on-the-job events.
- Author and enforce role-based training curriculum on the fly
- Automate email reminders for new and interval training assignments
- Produce detailed reporting by curricula, role, training item type, or individual
- ISSUES MODULE: Build custom, closed-loop processes like CAPAs and Deviations for any event type.
- Design multistage processes with custom electronic forms and workflows
- Include stages for root cause analyses and effectiveness checks
- Automate issue notifications and investigator assignments
- Create dashboards to measure process throughput and activity
- CHANGE CONTROL MODULE: Keep your finger on the pulse of changing processes.
- Configure forms and stages to match your current processes
- Assign granular permissions for access and escalation
- Ensure timely follow-up by creating & managing sub-tasks for each stage
- AUDITS MODULE: Streamline your entire GxP audit and supplier qualification process.
- Call up and organize an approved vendor list
- Set an evergreen audit calendar to update as you work
- Establish a feedback loop for risk management with reports and trends
The business is built on an established and well-respected client base, and growing rapidly. We’ve been able to cultivate an environment that is both collegial and entrepreneurial, but still retains a bit of early-stage fun. Our headquarters is located in Ardmore, PA.
To be successful in this role you must:
- Have excellent written and verbal communication skills and enjoy working in a transparent environment.
- Have the self-discipline to achieve continuous improvement in your technical & professional skills and the ability to apply those skills through the enhancement of software development team processes.
- Be comfortable working in a distributed team.
- Have working knowledge and experience of distributed cloud architectures.
- Test and adopt new technologies as they are introduced to the company and the software development domain.
- Have extensive experience delivering working software in a complex SDLC using .NET / C#, JavaScript/Node.js, SQL, HTML, CSS.
- Have working knowledge and experience of code management tooling and patterns.
- Be comfortable giving and receiving technical-feedback and training through code review and ad-hoc processes.
- Serve as a key stakeholder in infrastructure related incident response, especially when pertaining to data integrity.
- Adhere to company’s core values
- Be Kind: Honesty, transparency, and kindness fuels everything we do, from the way we interact with each other to the way we build our business and support our clients.
- Keep it Simple:Nobody wants to add more complexity to their day. Whether we’re building software or guiding clients along their GxP journeys, we keep it simple.
- Always be Improving:Continuous improvement isn’t just a buzzword. Every day we aim to be better for our employees, our community, and our customers.
Be Part of the Community: Together, we’re better. We’re intentional with our participation and support for the Quality community, as well as the communities in which we work and live.
Areas of Experience:
- .NET / C#
- React Development Tools
- HTML
- CSS
- JavaScript / TypeScript
- SQL
- Git / GitHub
Requirements
- B.S. in Computer Science or related area of study.
- 8+ years in progressive, hands-on, software engineering roles.
- 3+ years working with .NET / C#
- 2+ years working with JavaScript, SQL, HTML, CSS
- 1+ years working with TypeScript.
- 3+ years working with AWS Cloud services.
- Nice to have: Node.js experience
- Demonstrable experience with relational databases, and a base understanding of data modeling
- CEFR Level B2 or higher in English - comfort and familiarity with written and oral communications is necessary.
- Hybrid SDLC process experience including a blend of waterfall and agile methodology.